Incorrect Label: The label on the back of the device may show Model 2500A rather than Model 2500.

FDA DeterminedCause 2

TRAINING: Employee Error

Action

An Urgen Field Action letters was sent (10/11/07) to Nonin distributors who received the potentially mislabeled product. The letters provided labeling differences and included instructions for notifying their customers, with a response form to be returned to Nonin. For additional information please contact Kim Aves at 763-577-3196.